Full Job Description
The Clinical Trial Leader (CTL) provides leadership and management to the Clinical Research Associates (CRAs) and other clinical functional groups, in their day to day clinical trial activities, to include direct communication and interaction with investigative sites and team members on a global, multi-country or regional basis. The CTL is responsible for managing the planning, implementation, and tracking of the clinical monitoring process. The position requires an active role in developing the plan and monitoring of both resource allocation and clinical trial so that all aspects of the plan are in progress. The CTL serves as a proactive member of the core project team, liaising closely with the Project Manager (PM) on all study-related issues. The CTL will perform tasks with minimal supervision whilst assisting, mentoring and supporting the CRA teams.
Manage the study start up in collaboration with PM, Regulatory Lead and, if applicable, Global Site Activation Manager (GSAM).
Coordination and oversight of Critical documentation collection, maintenance and filing
Preparing Monitoring Plan (forward to PM for review and approval; providing input to TMF Plan and to other study plans. Ensure all monitoring plans are implemented.
Contributes to the development of CRF guidelines and edit checks.
Customizing Site Visit Report checklists/templates and their annotated versions according to study specific requirements.
Develop or modify templates to be used for monitoring activities according to study requirements.
Selection of investigators and sites; Site Evaluation Visit (SEV) report review and approval.
Site initiation management; Site Initiation Visit (SIV) report review and approval.
Monitoring Visit Report (MVR) review, management, resolution and escalation.
Manages successful trial close-out, identifies critical activities to make timely and efficient close-out.
Responsible for timelines, budget and quality of Clinical Monitoring team deliverables, identification of risks and issues and escalation to PM and Line Manager.
Coordinate and manage site visit schedules.
Manages CRA site assignments and schedules.
Develop patient recruitment and retention plans.
Provide information and input about planned activities to PM for the regular Project Review Meetings and attends Project Review Meetings if needed.
Conducts project co-monitoring (if required) and team training.
Site contact for protocol clarifications and subject enrollment if CRA unavailable.
Monitor and manage trial materials supplies. Ensures Investigational Product and other study supplies are shipped to sites.
Reviews data listings and query reports to identify trends and ensures proactive re-training is conducted with CRAs and site staff.
Oversees the process of protocol deviation documentation, tracking and escalation.
Participates in the development of study newsletters communication.
Relays project status and issues to PM.
Requests through the PM appropriate Clinical Operations staffing, workload and resources and reports study deliverables and resource needs.
Assists, where appropriate, the PM in discussions with clients on study documentation issues or technical related documentation concerns that may arise.
Reviews study systems (CTMS, CRF, central lab portal, etc.) updates on regular basis, ensures systems reports are up to date and reports generated are current and correct.
Coaches/mentors CRA team.
Develops and delivers project-specific training and provides input to Project Specific Training Matrix
Ensures project consistency within and across projects by following ClinChoice SOPs.
Assists and supports in the preparation of study specific training matrix and various training material used by ClinChoice (including SOPs training, as well as specific-therapeutic area related). Assists and supports web based training material preparation. Assists when needed in the preparation of company and scientific/medical presentations to potential clients and at Investigators’ meetings and other committees’ meetings as requested.
Assists in revision of Site Budgets and manages Investigator and Site Payments.
Contributes to case management and timely closure.
Supports PM in the management of study vendors as required.
Provides input into proposals when required.
Actively participates in preparation, attendance and presentation of bid defense or any other study related meetings.
May be assigned to monitor 1-2 sites.
Other duties as assigned.
Reports to Regional Lead, Clinical Trial Leadership or designee Line Manager.
Collaborates with Project Management, Data Management QA and other ClinChoice departments.
Liaises with clients as requested by the PM.
A degree in life sciences or nursing qualification preferred.
A minimum of 6 years clinical research experience with at least 1 year Lead CRA or other relevant team leadership experience.
Ability to mentor and train other CRAs in a positive and effective manner
In-depth knowledge of clinical trials and the critical elements for success in clinical trials
Strong therapeutic background.
Possesses experience and knowledge in the CRO industry that will support ClinChoice’s management of clinical trials.
Demonstrates the ability to successfully manage people/project issues.
Track and report on key performance indicators (KPI’s).
Mature management skills demonstrated by calm and thorough review of situations. Proactively identifies and addresses problems. Seeks to understand all contributing factors. Proposes, implements, and evaluates appropriate resolutions.
Demonstrates the ability to define and meet project requirements.
Demonstrates flexibility for improvement and creating solutions.
Proven organizational abilities, and excellent written and oral communication skills.
Excellent team player with team building skills.
Strong customer focus.
ClinChoice is an Equal Opportunity Employer / Committed to Diversity.